Protocol HNS 94-001 
October 4, 1994 
THE UNIVERSITY OF TEXAS 
M. D. ANDERSON CANCER CENTER 
Protocol 
Protocol Title: Clinical Protocol for Modification of Tumor Suppressor Gene Expression 
in Head and Neck Squamous Cell Carcinoma (HNSCC) with an 
Adenovirus Vector Expressing Wildtype p53 
Abstract 
1.0 Objectives Page 
2.0 Background and Rationale Page 
3.0 Safety Information Page 
4.0 Patient Eligibility Page 
5.0 Treatment Plan Page 
6.0 Pre-Treatment Evaluation Page 
7.0 Evaluation During Study Page 
8.0 Criteria for Response and Toxicity Page 
9.0 Criteria for Discontinuing Therapy Page 
10.0 Data and Protocol Management Page 
11.0 Statistical Evaluation Page 
12.0 References Page 
Appendix A: Evaluation Before and During Therapy 
Appendix B: Zubrod Scale of Performance Status 
Appendix C: Toxicity Criteria 
Appendix D: Figures/Figure Legends 
Appendix E: Biosafety Precautions 
Appendix F: Informed Consent 
Recombinant DNA Research, Volume 20 
[641] 
